Kornimate/medical-research-clean huggingface dataset:
neoadjuvant capecitabine, oxaliplatin, docetaxel and atezolizumab in resectable gastric and ge-junction cancer (panda)

Conditions: Stomach Cancer; Gastro Esophageal Junction Cancer

Summary: in this explorative study, patients with resectabel cancer of the stomach or stomach-oesophagealjunction cancer will receive neoadjuvant treatment. the treatment will be 1 cyle atzolizumab monotherapy, followed by 4 cycle of atezolizumab and capecitabine, oxaliplatin and docetaxel.

in this single-centre, open-label, monocenter study, the investigators will enroll 20 patients with resectable cancer of the stomach of gejunction. all patients will be treated with 1 cycle of atezolizumab monotherapy, followed by 4 cycles of combinationtherapy of atezolizumab, capecitabine, oxaliplatin and docetaxel, followed by surgery.

Eligibility criteria:
inclusion criteria: * signed informed consent * patients age 18 and older * primary resectable, histologically confirmed gastric or gej adenocarcinoma exclusion criteria: * no signs of distant metastases * no active or history of autoimmune disease or immune deficiency * no significant cardiovascular disease * no major surgical procedure within 4 weeks prior to initiation of study treatment * no current treatment with anti-viral therapy or hbv * no pregnancy or breastfeeding * no history of malignancy within 3 years prior to screening

Keywords: short term immunotherapy surgical resection atezolizumab capecitabine oxaliplatin docetaxel
predictors of asthma exacerbations in children

Conditions: Asthma

Summary: the purpose of this study is to determine whether parameters of the pulmonary function tests and the bronchial hyperresponsiveness to methacholine are predictors of asthma exacerbations.

preliminary investigations from our own research group showed that lung function parameters (fev1, the fev1/fvc ratio and a moderate to severe hyperresponsiveness to methacholine challenge were risk factors of asthma exacerbations (or 11.3). in the present study, these parameters will be evaluated in prospective design. one hundred children will be included in the study. baseline parameters will be collected in a healthy interval (visit 1), then the children will be followed up for 1 year. if the patients fulfill the criteria for an exacerbation the children will present in our department. we expect that 44% of the children have an exacerbation. all children will present at a second visit after one year (visit 2).

Eligibility criteria:
inclusion criteria: * informed consent * age \>3 and \<7 years * diagnosis of intermittent asthma * in the last 24 months, at least 6 weeks of treatment with a controller medication (inhaled steroid and / or leukotriene receptor antagonist singulair ®), or in the last 12 months, at least three episodes with an use of controller medications (inhaled steroid and / or the leukotriene receptor antagonist singulair ®) * the ability to perform three reproducible spirometries * examination in infection-free interval (\> 4 weeks infection-free) * minimum distance to the following asthma medications: * short-acting beta 2-agonists: 8 hours * ipratropium bromide: 24 hours * long-acting beta 2-agonists: 24 hours * steroids: 4 weeks * leukotriene antagonist: 4 weeks exclusion criteria: * age older than 6 years or younger than 4 * the inability to perform spirometry * other chronic diseases or infections (eg. hiv, tuberculosis, malignancy) * participation in another study

Keywords: asthma children predictors of exacerbation methacholine challenge pulmonary function testing
influence of dietary nitrate on vascular dysfunction and inflammation

Conditions: Cardiovascular Diseases

Summary: the principal research objective is to determine whether inorganic nitrate in the form of beetroot juice compared to placebo control prevents the systemic inflammation that underlies typhoid vaccine-induced endothelial dysfunction

we wish to determine in a prospective manner whether inorganic nitrate affects the endothelial dysfunction induced by systemic inflammation. at baseline we will measure flow-mediated dilatation (fmd) and peripheral augmentation index, as well as aortic stiffness, as measured by pulse wave velocity (pwv). volunteers will then receive \~8 mmols of dietary nitrate or nitrate free placebo juice once daily for 6 days. after this, depending on availability, volunteers will receive a typhoid vaccine typherix®, glaxosmithkline uk or typhim vi ™, aah pharmaceuticals ltd). this vaccine generates a mild systemic inflammation that is associated with vascular dysfunction. all vascular function measures will be repeated at 8 hours and 32 hours after vaccine administration.

Eligibility criteria:
inclusion criteria: 1. healthy volunteers 2. aged 18-45 3. volunteers who are willing to sign the consent form. 4. normal resting blood pressure (\<140/90 mmhg) exclusion criteria: 1. healthy subjects unwilling to consent 2. pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result 3. history of any serious illnesses, including recent infections or trauma 4. subjects taking systemic medication (other than the oral contraceptive pill) 5. subjects with self-reported use of mouthwash or tongue scrapes 6. subjects with recent (3 months) or current antibiotic use 7. subjects with a history, or recent treatment of (within last 3 months) any oral condition (excluding caries), including gingivitis, periodontitis and halitosis 8. subjects with a history of typhoid vaccination in the last 6 months 9. subjects with any history of a blood-borne infectious disease such hepatitis b or c virus, or hiv
prevalence of functional gastrointestinal disorders (fgids), related signs and symptoms in infants/toddlers in thailand

Conditions: Functional Gastrointestinal Disorders

Summary: prevalence and impact of functional gastrointestinal disorders (fgids) and related signs and symptoms in infants and toddlers in thailand

primary: to assess the prevalence of specific fgids (infant regurgitation, infantile colic and functional constipation) and related signs and symptoms in infants and toddlers in thailand, according to information provided by the parents. secondary: to assess the impact of fgids (infant regurgitation, infantile colic and functional constipation) and related signs and symptoms of infants and toddlers on the quality of life (qol) of parents/caretakers and family, according to information provided by the parents. exploratory: to assess treatments and practices employed in real-life to manage fgids according to the rome iv criteria (infant regurgitation, infantile colic, and functional constipation) and related signs and symptoms in infants and toddlers, according to information provided by the parents.

Eligibility criteria:
inclusion criteria: 1. parent of otherwise healthy infants and/or toddlers from one of the age groups: 3±1 months, 6±1 months, 9±1 months, 12±1 months, or 18±1 months 2. parent answering the online survey questionnaire attends to the child more than 50% of the time 3. informed consent from one or both parents (according to local laws) and/or legal guardian. 4. parent should have reliable access to the internet and a reliable device such as a computer, tablet or smartphone to complete the online survey questionnaire exclusion criteria: 1. parent who is not adequately comfortable in the language in which the online survey questionnaire will be completed 2. inability of the parent to answer the survey questionnaire online. 3. infants and toddlers who underwent surgery under general anesthesia
aminocamptothecin in treating patients with t-cell lymphoma

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of aminocamptothecin in treating patients with advanced cutaneous t-cell lymphoma.

objectives: i. assess the antitumor activity of aminocamptothecin (9-ac) administered by 72-hour infusion in patients with advanced cutaneous t-cell lymphoma. ii. assess the toxic effects of 9-ac administered on this schedule. outline: single-agent chemotherapy. aminocamptothecin, 9-ac, nsc-603071. projected accrual: a total of 30 patients will be accrued; if no more than 1 response is seen in the first 15 patients, the study will close. probable duration of study is 18 months.

Eligibility criteria:
disease characteristics: histologically confirmed, advanced stages iib/iii/iv cutaneous t-cell lymphoma measurable or evaluable disease required measurable disease includes: skin disease evaluated by clinical assessment grid method lesion measurable on imaging (i.e., ct measurement of lymph nodes) pure osteolytic lesion unidimensional lesion for which a normal measurement is available (e.g., mediastinal width on x-ray) evaluable disease defined as malignant disease evident on physical or radiographic exam but not measurable by ruler or caliper, i.e.: pelvic masses confluent multinodular lung metastases skin metastases cns metastases eligible if stable for at least 4 weeks following completion of surgery or radiotherapy patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: at least 3 months hematopoietic: anc at least 1,500 platelets at least 100,000 hepatic: bilirubin no greater than 1.5 mg/dl ast less than 3 times normal renal: creatinine no greater than 1.5 mg/dl other: no contraindication to indwelling central venous catheter no active infection including hiv no other medical condition that would preclude protocol compliance no pregnant or nursing women adequate contraception required of fertile patients prior concurrent therapy: biologic therapy: prior biological therapy allowed chemotherapy: prior systemic chemotherapy allowed patients with more than 1 prior regimen analyzed separately at least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) endocrine therapy: not specified radiotherapy: prior skin irradiation allowed at least 4 weeks since wide-field radiotherapy surgery: fully recovered from prior surgery other: prior topical therapy allowed prior puva allowed

Keywords: stage ii cutaneous t-cell non-hodgkin lymphoma stage iii cutaneous t-cell non-hodgkin lymphoma stage iv cutaneous t-cell non-hodgkin lymphoma recurrent cutaneous t-cell non-hodgkin lymphoma
cough assessment in patients with severe acquired brain injury

Conditions: Tracheostomy Complication; Acquired Brain Injury; Brain Injury; Pneumonia

Summary: the cough assessment is fundamental in the weaning process as it gives information on the possibility to expel food and secretion out from the airways. the majority of persons suffering from severe acquired brain injury are not able to cough voluntary due to severe cognitive deficit. in the present study, it would be evaluated the intensity of the reflex cough (rc) and the results would be correlated with weaning outcome.

all the participants will undergo firstly to the rc assessment. rc would be trigged by the inhalation of 0.4m of citric acid solution using the ultrasonic nebulizer (mo-03 norditalia elettromedicali). the face mask would be connected with the spirometer and the nebulizer via a bidirectional valve in order to measure peak of cough expiratory flow (pcef) of the rc. secondly, it would be assessed parameters of the weaning protocol in order to verify the feasible of removing the tracheostomy cannula. hence, if the previous assessments are positive, the cannula 's patients would be removed. the follow-up would be taken after 96 hours from the decannulation in order to verify the outcome of weaning. in this study, it would be recruited a number of 30 consecutive patients admitted to irccs ospedale san camillo. the data would be firstly analyzed using kolmogorov-smirnov test in order to verify the distribution. secondly it would be chosen to t-test for parametric outcomes or wilcoxon non parametric outcomes. thirdly, the correlation between the peak of cough expiratory flow of the rc and the weaning outcome would be completed using pearson test (parametric) or spearman test (non parametric).

Eligibility criteria:
inclusion criteria: * diagnosis of acquired brain injury * presence of tracheostomy cannula and positive cupping trial * provide informed consent independently exclusion criteria: * presence of allergy to citrus; * presence of asthma * presence of mechanical ventilation; * presence of trachomalacia * presence of laryngeal stenosis

Keywords: cough reflex test decannulation
a phase i study of pcur-101 in combination with androgen suppression therapy in the treatment of patients with metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-Resistant Prostate Cancer

Summary: this is an open label, non-randomized, phase i, dose escalation/dose expansion study of pcur-101 in combination with androgen suppression therapy in the patients with metastatic crpc


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of metastatic crpc * standard of care androgen deprivation treatment * castrate serum level of testosterone of ≤ 50 ng/dl (≤ 1.73 mmol/l) * progressive disease while receiving androgen deprivation therapy * previously treated with abiraterone, enzalutamide alone or in combination and must have demonstrated evidence of objective progression as per pcwg3 criteria * adequate hematologic, renal and hepatic function * kps of ≥ 70 or ecog of 0 to 1 exclusion criteria: * pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology * use of opiate analgesics for prostate cancer pain within 4 week of treatment start * more than one sequential second generation ar-directed therapy * received cytotoxic chemotherapy for either metastatic hspc or crpc within the last 12 weeks or other investigational agents within 4 weeks * history of bleeding disorder * history of seizure disorder * concomitant use of therapeutic anticoagulation * history of or current cardiac issues * received external beam radiation therapy within 4 weeks * ctcae grade \> 2 neuropathy
muscle strength training for older adults with type ii diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this randomised controlled trial aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with type ii diabetes (t2 dm). 60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group. muscle strengthening group will receive resistance training 3 times per week (1 hour/session). the control group will not receive any training but can continue usual medical care and daily activities. primary outcomes: glycemic control and lipid profile secondary outcomes: muscle mass and strength, and functional capacity data will be collected at baseline (pre-test) and after a 4-month intervention (post-test).

this study aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with type ii diabetes (t2 dm). this is a single-blinded, randomized controlled trial. 60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group. information on demographic characteristics, body composition, muscle strength, functional capacity and glycemic control will be collected at baseline (pre-test) and after a 4-month intervention (post-test). muscle strengthening group will receive resistance training 3 times per week (1 hour/session). the control group will not receive any training but can continue usual medical care and daily activities.

Eligibility criteria:
inclusion criteria: * t2 dm * 60-75 years old * ability to perform exercise exclusion criteria: * advanced hypertension (≥ 160/100 mm hg) * severe obesity (bmi ≥ 48kg/m2) * insulin pump user * coronary heart disease history * chronic obstructive pulmonary disease * advanced neuropathy * learning or mental disorder, or * any other diseases that prevent subjects from exercising safely. * those who participate in regular resistance or aerobic exercises will also be excluded.

Keywords: resistance training diabetes mellitus blood-glucose control muscle function
a phase ii study of dmp 115 to assess focal liver lesions

Conditions: Liver Disease

Summary: to determine the optimal dose of dmp 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.


Eligibility criteria:
inclusion criteria: * diagnosed with 1 but \<7 focal liver lesions * scheduled for liver biopsy within 30 days of study * scheduled for ct or mr within 30 days of study exclusion criteria: * critically ill subjects * subjects with right-to-left shunts
optic nerve sheath diameter (onsd) with the raised pco2 and internal jugular venous occlusion

Conditions: Elevated Intracranial Pressure (ICP)

Summary: monitoring the icp is the most important aspect of the management of these patients. recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be useful in the diagnosis of raised icp by evaluating the change in the optic nerve sheath diameter (onsd). transorbital ultrasonographic measurement of onsd appears to be a noninvasive, relatively inexpensive bedside examination for the diagnosis of raised icp. the investigators aimed to determine the changes in onsd with acute controlled changes in icp in healthy volunteers. the controlled changes in icp will be produced by manipulating the pco2 with the use of respiract and jugular venous compression with the use of custom made neck collar.

elevated intracranial pressure (icp) is a common and potentially life threatening condition arising from a variety of pathological conditions including traumatic brain injury (tbi), intracranial hemorrhage, subarachnoid hemorrhage and brain tumors. monitoring the icp is the most important aspect of the management of these patients. recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be useful in the diagnosis of raised icp by evaluating the change in the optic nerve sheath diameter (onsd). transorbital ultrasonographic measurement of onsd appears to be a noninvasive, relatively inexpensive bedside examination for the diagnosis of raised icp. the investigators aimed to determine the changes in onsd with acute controlled changes in icp in healthy volunteers. the controlled changes in icp will be produced by manipulating the pco2 with the use of respiract and jugular venous compression with the use of custom made neck collar.

Eligibility criteria:
inclusion criteria: adult healthy volunteers who are above the age of 18 asa 1 body mass index (bmi) less than and equal to 35 neurologically normal subjects with no symptoms other than occasional non-severe headache exclusion criteria: bmi above 35 lack of informed consent language barrier medical students and/or anesthesia residents going through the department as part of their rotation pregnancy frequent migraine headache
myocardial micro-damage in relation to active and passive fixation pacemaker electrodes

Conditions: Bradyarrhythmia

Summary: pacemaker electrodes are either equipped with tines (passive fixation) or with a screw (active fixation) for initial fixation in the patient´s heart. both types of electrodes provide similar results in a long-term follow-up and the use of one or the other electrode type in many instances is mainly based on the implanter´s preference. the pacman-trial investigates whether the two lead types are associated with different amounts of myocardial micro-damage during implantation.


Eligibility criteria:
inclusion criteria: * de-novo implantation of a pacemaker system exclusion criteria: * aai pacing or cardiac resynchronization therapy * icd indication * temporary pacing * lead revision * right ventricular pacing aimed from alternative pacing sites (other than the apex) * lead revision * severe tricuspid valve regurgitation * previous myocardial infarction, coronary intervention, stroke, cardioversion or ablation in the presence of elevated troponin levels * dialysis
eradication of h. pylori infection with moxifloxacin

Conditions: Helicobacter Pylori Infection; Helicobacter Pylori Infection, Susceptibility to

Summary: the main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance.

patients who were confirmed to be positive for helicobacter pylori infection were randomly assigned to the eradication treatments. at four weeks after completion of eradication therapy, h. pylori tests were performed with a stool antigen test.

Eligibility criteria:
inclusion criteria: 1. successful isolation of h. pylori from the patient, and 2. patients of at least 18 years of age. exclusion criteria: 1. age under 18 years 2. presence of clinically signiﬁcant associated conditions (insulin-dependent diabetes mellitus, gastrointestinal bleeding, neoplastic diseases, coagulation disorders, and neurologic, metabolic, hematological or endocrine hepatic, cardiorespiratory, or renal diseases), 3. previous gastric surgery, 4. allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.

Keywords: triple therapy with moxifloxacin helicobacter pylori levofloxacin sequential therapy stool antigen test
gas embolism with use of argon plasma coagulation

Conditions: Embolism, Air

Summary: the purpose of this study is to use transesophageal echocardiography (tee) to determine the incidence, severity, and clinical significance of gas bubbles during argon plasma coagulation (apc).

gas embolism is a rare but serious complication of apc. we will use tee to monitor for gas bubbles during apc. apc will be terminated if gas bubbles are associated with ischemic heart rhythms, wall motion abnormalities, or if large gas bubbles are noted in the left ventricle.

Eligibility criteria:
inclusion criteria: * adults (male and female) 18 years of age or older * clinical indication for bronchoscopy (hemoptysis, airway obstruction, tumor excision, granulation tissue that is impairing endobronchial stent performance) * ability of the patient or proxy to read, comprehend, and sign informed consent document. exclusion criteria: * presence of esophageal disorders that may complicate transesophageal echocardiography (strictures, varices, fistula, prior esophageal surgery) * presence of coagulopathy or other bleeding diathesis * inability to tolerate brief periods of apnea * presence of pulmonary vascular disease * pregnant women will not be included in this study because the potential fetal hypoxemia is not an acceptable risk. * no exclusions will be made based on gender or race.

Keywords: embolism argon
the negative pressure wound therapy in flap enhancement: clinical evaluation study

Conditions: Surgical Flap; Negative-Pressure Dressings

Summary: the goal of this study is to compare the clinical outcomes of using npwt dressing versus conventional dressing in improving flaps outcome

the cases will be divided into 3 major study groups: 1st group will be managed with high negative pressure wound therapy the 2nd group will be managed with low negative pressure wound therapy the 3rd group will be managed with conventional dressing

Eligibility criteria:
inclusion criteria: - adult patients skin and soft tissue defects that need flap coverage exclusion criteria: * associated severe regional injuries uncontrolled comorbidities